Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in VIH Infection.

HIV -1 Infection Clinical Trial

Official title:

Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in VIH Infection.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01908049
• Other study ID #: PROB-VIH
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 22, 2013
• Last updated: November 11, 2016
• Start date: August 2012
• Est. completion date: March 2017

Study information

• Verified date: November 2016
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Objectives: MAIN: To evaluate the parameters of microbial translocation after treatment with probiotics (Saccharomyces boulardii) in HIV+ patients and its role on immune reconstitution and the changes in gut microbiota composition.

SECONDARY OBJECTIVES: 1) To analyze the progress of immune activity markers after the administration of probiotics. 2) To determine the improvement of CD4+ lymphocytes and HIV viral load in patients after taking probiotics.

Methods: Design: A prospective randomized open controlled double-blinded trial, to be performed at a tertiary care hospital in Barcelona. Subjects: Chronic HIV infected patients. Sample size: 44 cases. They´ll be divided in 2 groups: (1) Patients with CD4 +> 400 cells / ml and undetectable viral load for more than two years (22 cases) and (2) Patients with immunodiscordancy, defined as patients with CD4 + T cells lower than 350 cells / ml despite 4-7 years of effective antiretroviral therapy. (22 cases). Intervention: Patients were randomized in 2 subgroups: (A) they´ll receive daily oral supplementation with S. boulardii for 3 months and (B) they ´ll receive placebo. Variables: bacterial lipopolisaccharide levels measured by the Lipid-Binding protein (LBP), parameters of immune activation in plasma (soluble CD14, IFN-Υ, TNF-Alpha, IL (interleukine)-2, IL-5, IL-6, IL-12)and gut microbiota composition prior to the use of probiotics (baseline), at 3 and 6 months. Immunological and clinical data. Outcome measures: quantification of bacterial translocation levels, markers of activity and immune recovery. Analysis: Comparison of variables before and after the intervention. The analysis will be performed by biological and immunological effectiveness.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: March 2017
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with chronic HIV infection and viral load undetectable > two years with stable ART CD4> 400 cells / ml.

• Patients with chronic HIV infection and viral load undetectable> two years with stable ART CD4 <350 cells / ml.

• Inform consent signed.

• Aged between 18- No limit.

Exclusion Criteria:

• Patients who receive or have received in the past 6 months food supplements containing probiotics.

• Patients who have received antibiotic treatment in the last two months

• Patients who are poor presupposes adherence to dietary supplements.

• Patients who have changed the TAR in the last three months.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• HIV -1 Infection
• Infection

Intervention

Dietary Supplement:
• Probiotic.

• Placebo

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate microbial translocation-Binding lipopolysaccharide Protein (LBP).		From randomisation to 6 months.	Yes
Primary	To evaluate Gut microbiota composition.	Change in gut microbiota (454 pyrosequencing of fecal samples).	From randomisation to 6 months.	No
Secondary	To evaluate Markers of immune activity: soluble CD14 (sCD14), interferon gamma (IFN-?), tumor necrosis factor (TNF), IL-6, Reactive C protein, D -dimer, fibrinogen.		From randomisation to 6 months.	No
Secondary	Analyse parameters that determine the immune status: CD4 + lymphocyte count, CD 8 + and HIV viral load.		From randomisation to 6 months.	Yes